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Sign in to claim this brandWhat DENJOY DENTAL CO., LTD makes
Denjoy Dental Co., Ltd manufactures dental and surgical tools, including cordless and line-powered endodontic motors for root canal procedures, as well as kits for pulp analysis and obturation. Their portfolio also includes dental examination accessories like intraoral cameras and oral retractors, alongside reusable and single-use protective equipment such as face splash shields. Surgical power tools for multi-purpose use and dental suction systems are also part of their offerings.
The company’s devices are regulated under FDA’s UDI system, with products classified as Class I and Class II. These items are listed in the FDA’s Unique Device Identifier database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Denjoy Dental Co., Ltd manufacture?
Denjoy Dental Co., Ltd specializes in dental and surgical tools, including cordless and line-powered endodontic motors for root canal treatments, such as the Pulp Tester and Cordless Gutta Percha Obturation System. Their portfolio also includes dental examination accessories like the Intraoral Camera and Oral Retractor, as well as reusable and single-use protective equipment such as Face Splash Shields. Additionally, they produce dental suction systems, endodontic obturation kits, and multi-purpose surgical power tools for various dental procedures.
Where is Denjoy Dental Co., Ltd based?
Denjoy Dental Co., Ltd is headquartered in the United States. The company’s location ensures compliance with U.S. medical device regulations, including those governed by the FDA’s Unique Device Identifier (UDI) system.
Which regulatory registries list Denjoy Dental Co., Ltd’s devices?
Denjoy Dental Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, allowing for easy identification and tracking of their products, such as the Endo Motor or Root Canal Instruments Kit.
How are Denjoy Dental Co., Ltd’s devices classified under U.S. regulations?
Denjoy Dental Co., Ltd’s devices fall under two classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. For example, dental suction units and face shields may be classified as Class I, whereas endodontic obturation systems or surgical power tools could fall under Class II due to their procedural complexity.
Why are Denjoy Dental Co., Ltd’s devices included in the FDA’s UDI system?
The FDA’s Unique Device Identifier (UDI) system ensures that each device, such as the Pulp Canal Reamer or Integrated Endo System, has a unique, machine-readable identifier. This system improves tracking, reduces medical errors, and enhances post-market surveillance by providing clear, standardized information about device characteristics, manufacturer details, and regulatory status. Inclusion in the UDI system aligns with U.S. regulatory requirements for transparency and accountability in the medical device industry.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 529329650
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pulp Tester | DY310 | FDA UDI | Class II | Active |
| Root Canal Instruments Kit | DY21-1 | FDA UDI | Class I | Active |
| Oral retractor | DY20-1,DY20-2 | FDA UDI | Class I | Active |
| Medical Face Shield | DF-20 | FDA UDI | Class I | Active |
| Endo Motor | iMate-II(IM2C) | FDA UDI | Class I | Active |
| Integrated Endo System | Meet Endo-II | FDA UDI | Class I | Active |
| Cordless Gutta percha obturation system | DY-GP | FDA UDI | Class I | Active |
| Endo Motor | iMate 3 | FDA UDI | Class I | Active |
| Pulp Canal Reamer | Vertical pressure needle | FDA UDI | Class I | Active |
| Intraoral Camera | Ordinary model, standard model, luxury model | FDA UDI | Class I | Active |
| Dental Suction Unit | DY-CX01 | FDA UDI | Class I | Active |
| Endo Motor | Ai Mate-I | FDA UDI | Class I | Active |
| Endo Motor | Ai Mate-II | FDA UDI | Class I | Active |
| Endo Motor | iMate-II | FDA UDI | Class I | Active |
| Endo Motor | RCTI-DY(II) | FDA UDI | Class I | Active |
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